Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.
Phase 2
Recruiting
- Conditions
- HER2 positive breast cancer
- Registration Number
- JPRN-UMIN000010579
- Lead Sponsor
- Department of gastroenterologic and breast surgery Kanazawa University,School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil 2) Active secondary malignancies 3) Bilateral invasive breast cancer 4) Severe complications (infection, diarrhea, paresis of intestine, obstruction of the intestines, uncontrolled diabetes mellitus, etc.) 5) Positive for HBs antigen and the history of HBV infection 6) Severe heart disease, or the patient who has past history of it 7) Severe mental disease or under treatment 8) Active gastrointestinal tract ulcer or bleeding 9) Severe bone marrow suppression, renal dysfunction, and liver dysfunction 10) Severe pleural effusion or ascites 12) Pregnancy or suspected pregnancy 13) Physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method